MAIDEN BIOSCIENCES

FDA Device Registration & Listing · Gaithersburg, MD, US · Registration 3012973796

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012973796
FEI Number
3012973796
Entity Name
MAIDEN BIOSCIENCES
City/State/Country
Gaithersburg, MD, US
Establishment Address
101 Lakeforest Blvd., Suite 390, Gaithersburg, MD 20877, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Maiden Biosciences, Inc. (Owner Number: 10052710)
Owner / Operator Contact Address
101 Lakeforest Blvd., Suite 390, Gaithersburg, MD 20877, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K040211
PMA Number
N/A

All Registered Proprietary Names

ECM3 Ag ECM3 Collagen Sheet Dressing

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2025-12-17
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-12-17
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2016-09-17
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2024-12-30
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2016-09-17

Official Correspondent

Mark Gorman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Maiden Biosciences, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K040211 Collagen Matrix, Inc. MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING 2004-02-27
K112888 Kensey Nash Corporation MESO WOUND MATRIX 2012-02-10
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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3031600472 TIGER WOUND CARE MEDICAL, LLC Conshohocken, PA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012973796. Last updated year: 2026. Please use registration number 3012973796 when referencing this establishment in official correspondence.
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